9/12/2005

NEW YORK (Reuters) - Months before the
Food and Drug Administration issued a safety alert in June about problems with Guidant Corp. heart devices, a company report to the agency showed that some of those units were short-circuiting, The New York Times reported on Monday.
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But the agency did not make that data public at the time because it treats the information it receives in such reports as confidential, the newspaper said, citing FDA records.

While the agency has a policy of reviewing the reports within 90 days, it is unclear whether regulators did so within that time frame or how they first interpreted the information, the Times said.

As part of a lengthy annual report that Guidant submitted to the FDA in February, the company disclosed data showing that one of its widely used defibrillators, the Ventak Prizm 2 DR, was short-circuiting at the rate of about one a month, a rate that some doctors say was troubling.

A month later, a college student who had one of those units implanted in his chest died of sudden cardiac arrest, the Times report said.

In June, the FDA issued an alert about the model, later updating it to say that the short circuits, while rare, posed a significant risk because they could render the device useless just when it was needed most.

The newspaper quoted Dr. Daniel Schultz, the director of the FDA's Center for Devices and Radiological Health, that it would tie up too many resources to review hundreds of filings the FDA receives each year and determine which data could be routinely released and what should be treated as confidential.

There was no immediate comment from Guidant.

The Times report said makers of defibrillators and pacemakers, which regulate heart rhythms, must file annual reports with the FDA that say how often, and why, their devices fail. The level of detail in these reports, which are submitted on paper, is far higher than is required for other medical devices because of their life-sustaining roles. Those filings also include much more data than the summaries that companies give to doctors.